There have been many attempts to produce a breast prosthesis for use by mastectomy patients. Such prosthesis are generally considered important to the psychological health of the patient. However, in order to be of benefit, a prosthesis must mimic the human breast sufficiently such that the wearer believes that the presence of the prosthesis will be undetected by those the wearer meets. In addition to the movement and appearance of the prosthesis, it must also be easy to use and comfortable to wear.
While prosthetic devices may be implanted, external prostheses have achieved widespread acceptance because they do not require additional surgery, avoid the risks and health hazards of implants, are easily changed such that the user may enjoy improvements in the technology, and are easy to use.
Early prosthetic devices utilized many different materials. Silicone gel became widely accepted for use in prosthesis because of its resilient properties. At one time in the art, silicone prosthesis were prepared having a weight comparable to the weight of a human breast. It was believed that this was advantageous because in the event that the user had one natural breast and one prosthetic breast, that the balancing of the weight would be important. However, it was determined that matching the weight resulted in user discomfort. In U.S. Pat. No. 4,380,569, the use of microspheres mixed into the silicone gel to reduce weight is disclosed for the manufacturer of a prosthesis. While this method achieved weight reduction, the introduction of glass spheres, the bonding of the spheres with the silicone gel, created a stiff product which did not mimic the human breast as well as silicone gel alone.
Thus, there has been a continued need for a prosthetic device which mimics the movements of a human breast, which is lightweight and comfortable to wear. The present invention has advantages of achieving reduction in weight to improve comfort for the patient while not sacrificing movement, feel and texture qualities of the prosthesis.